Antioxidant dressing therapy versus standard wound care in chronic wounds (the REOX study) Chronic wounds are a major clinical and economic problem for health care institutions because of their impact on the quality of life of both patients and caregivers. Wound healing is impaired when the wound remains in the inflammatory stage for too long. A range of factors that can delay the healing process have been described, and include the imbalance between proteases and protease inhibitors in the wound bed, bacterial colonization and the presence of biofilm, and oxidative stress. This project focus in an antioxidant dressing (Reoxcare®) that was developed by Histocell (Bizkaia, Spain). The components of this dressing act as free radical scavengers since two of them also have a synergistic antioxidant effect. Due to the innovative design, this antioxidant dressing combines the advantages of moist healing in exudate management and free radical neutralization, achieving wound reactivation. This dressing with antioxidant properties has been tested in animal models and in case series of patients with acute wounds and chronic wounds of various aetiologies showing favourable results in activating the healing process. However, there is currently no study comparing this new antioxidant dressing with standard wound dressings that maintain a moist environment that are used in routine clinical practice for the treatment of chronic wounds. This trial aims to fill this gap in the knowledge. Objectives The primary aim of this study is to compare the effect of an antioxidant dressing on the healing of chronic wounds against the use of dressings that create a moist environment (as standard clinical practice) in patients with hard-to-heal wounds. The secondary aims are to measure the intrapatient variation over time in the percentage of nonviable and granulation tissue in the wound bed and to measure the reduction in the wound area. Research team
- Inés María Comino Sanz. IP. University of Jaén.
- Pedro L. Pancorbo Hidalgo. Co-IP. University of Jaén.
- Begoña Castro Feo. Departament of I+D Histocell.
- Francisco P. García Fernández. University of Jaén.
- María José Díez Requena. Andalusian Health Service. Jaén.
- Juan Francisco Jiménez García. Andalusian Health Service. Almería
- Josefina Arboledas Bellón. Andalusian Health Service. Jaén
- Mercedes Muñoz Conde. Andalusian Health Service. Málaga
- Rafael Cabello Jaime. Andalusian Health Service. Malaga
- Francisco Javier García Díaz. Andalusian Health Service. Malaga
Methodology The REOX study is a multicentre, single-blind, randomized controlled trial with parallel groups: intervention group (antioxidant dressing) or control group (standard clinical practice using dressings that create a moist environment). It will run in primary health care centres of the Andalusian Health Service (Spain). The sample will be recruited from patients with wounds treated in one of the health care centres engaged in the study and according the established criteria. Each patient included in the study will be assessed by one clinical nurse at baseline and every 2 weeks (weeks 2, 4, 6 and 8). The follow-up of patients in both groups will be continued until week 8 or until complete healing of the wound if this occurs earlier. This study was approved by the Ethics Committee of Jaén and by the Spanish Agency for Medicines and Medical Devices. The protocol of the trial was registered at ClinicalTrials.gov Identifier: NCT03934671 https://bit.ly/30sStRf Results (The results will be published progressively) – Comino-Sanz, I.M., López-Franco, M.D., Castro, B. et al. Antioxidant dressing therapy versus standard wound care in chronic wounds (the REOX study): study protocol for a randomized controlled trial. Trials 21, 505 (2020). Related papers Castro B, Bastida FD, Segovia T, López Casanova P, Soldevilla JJ, Verdú-Soriano J. The use of an antioxidant dressing on hard-to-heal wounds: a multicentre, prospective case series. J Wound Care. 2017 Dec 2;26(12):742-750. doi: 10.12968/jowc.2017.26.12.742. Castro B, Palomares T, Azcoitia I, Bastida F, del Olmo M, Soldevilla JJ, Alonso-Varona A. Development and preclinical evaluation of a new galactomannan-based dressing with antioxidant properties for wound healing. Histol Histopathol. 2015 Dec;30(12):1499-512. doi: 10.14670/HH-11-646. Epub 2015 Jul 3.